IPHARMA provides full cycle of clinical development from early phase trials to registration and post-marketing PV.
Services
International standards and Regulatory Authorities make demands on drug developers and holders of marketing authorization to ensure safety.
IPHARMA provides the following pharmacovigilance services:
1. Pharmacovigilance system management
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Pharmacovigilance system master file development and adaptation
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Providing pharmacovigilance platform to drug developers and holders of marketing authorization
2. Pre-marketing pharmacovigilance
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Safety plan development
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Receipt, review, sending and tracking of SAE reports
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Receipt, review, sending and tracking of SUSAR and SAR reports
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Receipt, review, sending and tracking of DSUR and PSUR reports
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Organizing the work of Data safety monitoring board with the involvement of independent experts and arrangement of the meetings
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Providing the reports to Russian and EAEU Regulatory Authorities
3. Post-marketing pharmacovigilance
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Preparation of a Patient information leaflet based on the IB data and/or clinical study reports
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Risk management plan (RMP) preparation
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Post-marketing studies conduct
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Receipt, review, database entry and tracking of adverse reactions, individual intolerance and other circumstances that may cause risks for health and life of a patient when using a drug
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Analysis of databases and literature sources, search and validation of signals
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Internal reports preparation
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Periodic safety update reports (PSUR) reparation and its submission to the regulatory authorities of the EAEU and Russia
4. Pharmacovigilance Quality Assurance
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Pharmacovigilance training
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Pharmacovigilance audits